Gameto: Successful Implementation of Castor EDC in a High-Stakes Environment

Gameto is a biotechnology company whose mission is to redefine female reproductive health by developing therapies that improve lives.

With Fertilo – an ex vivo egg‑maturation system – Gameto aims to make IVF and egg freezing shorter, safer, and more effective. By making these processes easier and less expensive, Fertilo could lower barriers to adoption of IVF and egg freezing, unlocking more of the market and helping more families reach their reproductive goals.

To discuss how Gameto used Castor to run their global IVF trials, we sat down with their Chief Scientific Officer, Christian Kramme, and their Embryology Department Manager, Sabrina Piechota.

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Overview of Gameto's Challenge and Solution

• Industry: Biotechnology
• Challenge: Gameto needed to generate FDA-compliant safety and efficacy data across nine concurrent global studies with a clinical operations team of just three people and timelines requiring execution in weeks rather than months.
• Solution: The company leveraged Castor EDC to centralize global oversight, enabling their lean team to act as their own data management unit through remote source verification, synthetic control arms, and rapid, localized database builds.
• Result: Gameto achieved a record three-week protocol-to-live build time and delivered a pristine, audit-ready dataset that secured US IND clearance for immediate Phase 3 entry.

The challenge: high-stakes regulatory demands, limited resources

Gameto is a 20-person company with a clinical team of just three. Despite their size, they needed to move fast. The time between the conception of a clinical study to the execution is a matter of months.

Gameto needed to generate FDA-compliant safety and efficacy data across Peru, Mexico, and Australia to support a US IND submission. The operational reality was severe:

• Extreme Resource Constraints: Execute nine concurrent studies with a clinical operations team of just three people and no large CRO.
• Complex Longitudinal Safety: Manage longitudinal safety data, including infant development milestones, across diverse local standards.
• Rapid Deployment Needs: Deploy regulator-ready databases in weeks, not months, to meet aggressive milestones.

“We don’t have six months to set up a database. We’ve got six weeks, or three weeks. We have to learn as we go,” explains Christian. “We can’t just do an amendment that takes five weeks to go into process. We might have a couple days.”

The solution: centralized oversight of decentralized global sites

Gameto used Castor EDC to centralize oversight, allowing the core team to function as their own Data Management unit:

• Remote Source Data Verification (SDV): Enabled 100% remote monitoring by capturing high-resolution source documents (blood logs, charts) directly within the EDC for verification.
• Synthetic Control Arms: Integrated real-world data (RWD) to build case-matched synthetic controls, comparing Fertilo outcomes against conventional IVF cycles.
• Global Harmonization: Deployed fully localized Spanish CRFs for Latin American sites while maintaining a unified, FDA-compliant data structure for the central US regulatory submission.

They ran a total of nine studies, across four continents, with just three people. A 38-patient dataset—30 Fertilo, 10 control— moved the product straight into FDA Phase 3. Clean audit trails and rapid CRF versioning kept regulators comfortable.

“Most importantly, and what Castor has been such a huge help in, is getting the data back and really showing that the product is safe and effective, and data is being collected in a way that’s rigorous, reliable, and auditable,” states Christian.

The results: Data integrity that secured US IND Clearance

By controlling the build and monitoring process internally, Gameto eliminated vendor friction and delivered a pristine regulatory package:

• US IND Clearance: The 38-patient dataset—generated entirely ex-US—was accepted by the FDA for immediate Phase 3 entry.
• Longitudinal Safety: Successfully tracked 13 ongoing pregnancies and live births with full audit trails.
• 3-Week Build: Went from protocol-to-live for a randomized controlled trial (RCT) in Peru, including full Spanish localization.

Gameto is now expanding into a global head-to-head comparison of Fertilo vs. conventional IVF across Europe, Australia, the Middle East, and Southeast Asia—again with the same lean team, powered by Castor.

We launched a complex, bilingual trial in three weeks. Castor lets our small team operate at global scale without compromising compliance

Sabrina Piechota, Embryology Department Manager at Gameto

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